Calibration material delivery devices and methods

ABSTRACT

A device is described that includes: a first portion configured to be grasped by the hand of the user, and a second portion defining a reservoir containing a control material, wherein the control material contains a target analyte in a known or predetermined concentration. Related arrangements and methods are also described.

FIELD

The inventions described herein relates to devices and methods ofdelivering calibration or control information to a device, such as ananalyte monitor.

BACKGROUND

In this specification where a document, act or item of knowledge isreferred to or discussed, this reference or discussion is not anadmission that the document, act or item of knowledge or any combinationthereof was at the priority date, publicly available, known to thepublic, part of common general knowledge, or otherwise constitutes priorart under the applicable statutory provisions; or is known to berelevant to an attempt to solve any problem with which thisspecification is concerned.

Currently, analyte monitoring devices, such as blood glucose monitors,include a method of executing a “control fluid” test to determine if thedevice is functioning according to the manufacturer's expectations.Typically, users complete a “control” test by dispensing a variableamount of fluid onto a test strip from a vial packaged with the testkit. This vial contains a fluid within a known analyte concentration.After the users dispense the fluid onto the test strip the analytemonitor assumes the fluid is a body fluid and provides a result asusual. The device and/or the user can compare the concentration oftarget analyte measured by the device with the known concentrationcontained in the control solution as a measure of the accuracy of themonitoring device.

Current systems require the user to dispense the calibration fluid froma vial containing several doses of calibration fluid. When dispensingthe fluid the user must take care not to spill the fluid on the device,or on the testing surface. Completing a control test also requires thatusers have the dexterity to deliver a small droplet of control solutionfrom a vial onto the test strip; this is especially difficult whendiseases such as diabetes affect the patient's vision and tactilesensation.

A typical calibration or control test requires the following steps:

-   -   1. users find their control vial    -   2. ensure that the control solution is still within its        expiration limits    -   3. find a test strip    -   4. insert the test strip into the device or meter    -   5. place the device into “control test mode” (if applicable)    -   6. shake the bottle of solution    -   7. open the control vial (using two-hands)    -   8. carefully squeeze out enough control solution onto the test        strip or the finger, taking care not to damage the analyte        monitor by dispensing too much fluid    -   9. accurately deliver the control solution to the analyte        monitor    -   10. compare the result of the control test versus the stated        control range which may or may not be listed on the control vial    -   11. mark the control test in their logbook so that health care        professionals can remove this test from the users monthly        averages if so desired.

Currently many users of analyte monitors find executing a control testto be a burdensome experience that they often ignore. By ignoring thecontrol test users often will acquire erroneous information from theirmonitors, and this information may then be used to adjust drugtreatments. The use of inaccurate information can lead to seriousconsequesnces, such as hypoglycemia in diabetes patients from a dosageof insulin that is too high.

While certain aspects of conventional technologies have been discussedto facilitate disclosure of the invention, Applicants in no way disclaimthese technical aspects, and it is contemplated that the claimedinvention may encompass or include one or more of the conventionaltechnical aspects discussed herein.

SUMMARY

As used herein, “body fluid” encompasses whole blood, interstitialfluid, and mixtures thereof.

As used herein “integrated device” or “integrated meter” means a deviceor meter that includes all components necessary to perform sampling ofbody fluid, transport of body fluid, quantification of an analyte, anddisplay of the amount of analyte contained in the sample of body fluid.Exemplary integrated meters are described in: U.S. Pat. Nos. 6,540,675and 7,004,928; U.S. Patent Application Publication Nos. US 2008/0077048,US 2007/0179404, US 2007/0083131, US 2007/0179405, US 2007/0078358, andUS 2007/0078313. The entire contents of each of the above-listeddocuments are incorporated herein by reference.

As used herein, “control material” means a material having a knownand/or predetermined quantity or concentration of at least one, andpossibly a plurality of, analyte(s) contained therein. The material canpossess any suitable form. For example, the control material can be inthe form of a liquid, a solid, a granular solid, a gas, a gel, asolution, a suspension, or any combination thereof. The analyte cancomprise any suitable analyte. For example, the analyte can comprise oneor more of: glucose, bilirubin, alcohol, controlled substances, toxins,hormones, and/or proteins.

It is to be understood that reference herein to first, second, third andfourth components (etc.) does not limit the present invention toembodiments where each of these components is physically separable fromone another. For example, a single physical element of the invention mayperform the functions of more than one of the claimed first, second,third or fourth components. Conversely, a plurality of separate physicalelements working together may perform the functions of one of theclaimed first, second, third or fourth components. Similarly, referenceto first, second (etc.) method steps does not limit the invention toonly separate steps. According to the invention, a single method stepmay satisfy multiple steps described herein. Conversely, a plurality ofmethod steps could, in combination, constitute a single method steprecited herein. In addition, the steps of the method are not necessarilylimited to the order in which they are described or claimed herein.

It should also be understood that references herein to “the invention,”or similar language, is used to enhance readability and for convenienceonly, and should not be interpreted as a limitation on what iscontemplated and comprehended by this disclosure and the appendedclaims. Instead “the invention” is intended to be interpreted asencompassing the full scope of what is claimed, regardless of thecharacterizations of the specific exemplary and non-limiting embodimentsdescribed in the specification.

The present invention may address one or more of the problems anddeficiencies of the prior art discussed above. However, it iscontemplated that the invention may prove useful in addressing otherproblems and deficiencies, or provides benefits and advantages, in anumber of technical areas. Therefore the claimed invention should notnecessarily be construed as being limited to addressing any of theparticular problems or deficiencies discussed herein.

The invention can be useful with any device, but is particularlyapplicable to analyte monitors used in a home or clinical setting suchas glucose monitors. The invention provides users of such monitors witha device that allows them to quickly and easily deliver one or moredoses of calibration or control information to one or more devices, suchas an analyte monitor. The invention also provides for mechanisms andmethods that can automatically differentiate a calibration test from atypical test. This invention is aimed at devices requiring calibrationor the ability to execute a control test. For example, in the case ofanalyte monitors where an analyte of a known concentration is deliveredto the analyte monitor to ensure that it is functioning properly.According to the principles of the present invention, a typical user caneasily and quickly execute a proper calibration test to ensure devicefunctionality without assistance from a trained health careprofessional. Alternatively, the present invention can also be utilizedby medical professionals in a clinical setting.

The invention can be used with an integrated device or integrated meterof the type defined above. However, the invention is not limited to usewith fully integrated meters, and benefits can also be attained by usewith conventional (non-integrated) meters and other diagnostic deviceswhere collection of accurate data and analysis of data is important.

The invention can provide a device containing a single dosage, ormultiple doses of control material in a convenient easy-to-use package.The control material can be contained within an applicator that is largeenough for easy handling and sealed according to a number of alternativeways so that the risk of spillage or damage to the analyte monitor isgreatly reduced.

This device simplifies a control test and encourages users to perform acontrol test more often so that any problems with their analyte monitorscan be found more quickly.

The invention can provide for use of one or more dosage(s) of apredefined volume of control material, thereby ensuring more accuratedata by allowing users to deliver the required amount of controlsolution, unlike previous methods in which it is quite possible thatusers could deliver too much or too little control solution. Aspreviously mentioned, by sealing each dosage individually the viabilityof the control sample can be enhanced and users are less likely to useexpired control material. The accuracy of the average data stored withinthe analyte monitor can also be increased by automatically marking ordifferentiating a control test from a normal or actual test so that thecontrol test value can not impact the averages of normal analyte testing(weekly, monthly, etc) stored within the unit.

According to certain aspects, the invention provides mechanisms andmethods that can determine automatically if the sampled material is bodyfluid or control material without the user's intervention. Also, theindividual packaging of each control test ensures that each solutiondosage will remain enclosed in a protective environment and allows foran extended expiration date.

According to a first aspect, the present invention provides a devicecomprising: a first portion configured to be grasped by the hand of theuser; and a second portion defining a reservoir containing a firstcontrol material, wherein the control material comprises a targetanalyte of a known or predetermined concentration.

According to another aspect, the present invention provides incombination, an integrated meter comprising a housing with an openingformed therein, and the device as described above, the second portioncomprising a body and a flange shaped and configured to be received bythe integrated meter.

According to an additional aspect, the present invention provides amethod of conveying a control material to an analyte monitor, the methodcomprising: (i) providing a dispenser comprising a first portionconfigured to be grasped by the hand of the user, and a second portiondefining a reservoir having a frangible seal thereon, the reservoircontaining a control material, wherein the control material contains atarget analyte in a known and/or predetermined concentration; (ii)breaking the frangible seal; and (iii) conveying the control material toa location for analysis by the analyte monitor.

According to another aspect, the present invention provides a method ofverifying the accuracy of the operation of an analyte monitoring deviceusing a control material having a known and/or predeterminedconcentration of at least one analyte, the method comprising: providinga single or multi-test cartridge having information associated therewithdefining an acceptable range of measured analyte concentration valuesfor the control material; associating the single or multi-test cartridgewith the device; reading the information off the single or multi-testcartridge; introducing a control material to the single or multi-testcartridge; the device automatically determining the presence of acontrol material; analyzing the control material to measure theconcentration of analyte contained therein; and comparing the measuredconcentration with the control information to determine if the measuredconcentration corresponds to the acceptable range of concentrationvalues obtained from the information.

BRIEF DESCRIPTION OF THE DRAWING FIGURES

The following description of exemplary embodiments can be read inconnection with the accompanying drawings in which like numeralsdesignate like elements and in which:

FIG. 1 is a side view of a device formed according to one embodiment ofthe present invention.

FIG. 2 is a sectional view taken at line A-A of FIG. 1.

FIG. 3 is a bottom view of the device of FIG. 1.

FIG. 4 is a schematic illustration of a device and a possibleimplementation, use or method involving the device, according to furtheralternative embodiments.

FIG. 5 is a side view of a device formed according to an additionalalternative embodiment of the present invention.

FIG. 6 is a sectional view taken at line A-A of FIG. 5.

FIG. 7 is a perspective view of the device of FIG. 5.

FIG. 8 is an exploded perspective view of the device of FIG. 5.

FIG. 9 is a perspective view of a device formed according to anotherembodiment of the present invention.

FIG. 10 is a perspective view of one of the individual devices of FIG.9.

FIG. 11 is a top view of one of the individual devices of FIG. 9.

FIG. 12 is a side view of one of the individual devices of FIG. 9.

FIG. 13 is a bottom view of one of the individual devices of FIG. 9.

FIG. 14 is a side view of a device formed according to a furtherembodiment of the invention.

FIG. 15 is an edge view of the device of FIG. 14.

FIG. 16 is a longitudinal sectional view of the device of FIG. 14.

FIG. 17 is an exploded view of the device of FIG. 14.

FIG. 18 is a longitudinal sectional view of an alternative embodiment ofa device according to the present invention.

FIG. 19 is a side view of a further alternative embodiment of a deviceformed according to the present invention.

FIG. 20 is a longitudinal sectional view of the device of FIG. 19.

FIG. 21 is a longitudinal sectional view of an additional alternativeembodiment of a device of the present invention in a first state.

FIG. 22 is a longitudinal sectional view of the device of FIG. 20, in asecond state.

FIG. 23 is a side view of a yet another embodiment of a device formedaccording to the invention.

FIG. 24 is a longitudinal sectional view of the device of FIG. 23.

FIG. 25 is a sectional view of a further alternative embodiment of adevice of the present invention.

FIG. 26 is an enlargement of the detail of area B in FIG. 25.

FIG. 27 is a schematic illustration of certain techniques and mechanismsfor providing calibration information.

FIGS. 28A-28D illustrate a method and possible uses of a deviceaccording to further alternative embodiments of the present invention.

FIGS. 29A-29D illustrate an alternative method and possible uses of adevice according to additional alternative embodiments of the presentinvention.

FIGS. 30A-30B illustrate an additional alternative method and possibleuses of a device according to further alternative embodiments of thepresent invention.

DETAILED DESCRIPTION

In general terms this invention describes a device that allows a user todeliver a one or more doses of control material, such as a control fluidor control solution, to one or more devices such as a meter or monitor,for example, an integrated blood glucose monitor previously describedherein. The method of and apparatus for delivery of the control solutioncan take many forms, such as a prepackaged “blister” of control solutionor a “wand,” with a known predetermined volume of control solutionavailable for delivery to the analyte monitor. Exemplary, non-limitingembodiments of the present invention are illustrated in Figures whichfollow.

As illustrated in FIGS. 1-4, a device 10 constructed according to afirst illustrated embodiment comprises two portions; a first portion 12and a second portion 14. The first portion 12 serves primarily as ahandle for manipulation of the device 10 by a user. Thus, the firstportion 12 can be provided with any suitable form which provides thedesired functionality. Therefore, it should be evident that the form ofthe first portion 12 is not limited to the illustrated embodiment.According to the non-limiting illustrated embodiment, the first portion12 is in the form of an elongated cylindrical body.

The second portion 14 provides a mechanism for carrying a control orcalibration material, as well as optionally mating with a meter ormonitor (see, e.g. FIG. 4). Thus, the second portion 14 can have anysuitable form that provides this functionality. According to thenonlimiting illustrated embodiment, the second portion 14 defines areservoir 16. The reservoir 16 can have any suitable form, and is notlimited to the form shown in the illustrated embodiment. The reservoircontains a control material. Any suitable control material can beutilized. The control material comprises a target analyte, such asglucose, in a known and/or predetermined concentration. Optionally, thecontrol material may contain a plurality of target analytes. Accordingto one alternative embodiment, the control material is in the form of acontrol liquid or solution. According to a further alternativeembodiment, the control material is in the form of a liquid or solutionthat is carried by an absorbent or porous material, such as asponge-like material. Thus, according to the one optional embodiment,the control material 18 is in the form of an absorbent or porousmaterial having a control liquid, suspension or solution absorbedtherein.

The reservoir 16 containing the control material 18 can be provided witha closure or seal 20. The closure or seal 20 acts to contain the controlmaterial 18 within the reservoir 16, and to prevent contamination byshielding the control material 18 from the environment. The closure orseal 20 can be provided in any suitable form, and can be constructed ofany suitable material. According to one non-limiting example, theclosure or seal 20 can be in the form of a thin, frangible, closure,such as a metallic foil.

As noted above, according to one optional embodiment, the second portion14 serves to mate with an analyte monitor such that the control material18 can be dispensed. Thus, the second portion can be provided with ashape and size that renders it suitable for mating with a meter ormonitor. It should be evident that the construction of the particulardevice with which the second portion 14 will mate can influence both thesize and shape of the second portion 14. According to the nonlimitingillustrated example, the second portion 14 comprises a flanged 22cylindrical body 24, as perhaps best seen in FIG. 3, which isdimensioned to mate with an opening formed in an analyte monitor, asbest illustrated in FIG. 4. Thus, according to one possibleimplementation or embodiment of the present invention, an opening isformed in an analyte monitor by a flexible footprint or interface device26 which is mounted to the housing 28 of the meter or monitor. The body24 of the second portion 14 of the device 10 is inserted into theopening to a desired depth, which is controlled or defined by thelocation of the flange 22. According to one non-limiting example, theanalyte monitor includes a piercing element, or hollow needle, 30 whichcan be actuated such that it breaks the seal 20 and comes into fluidcommunication with the control material 18. The hollow piercing element30 then transports the control material 18 into the analyte monitor, asindicated by the arrow appearing in FIG. 4, wherein the monitor includesan appropriate mechanism for analyzing the control material to measurethe concentration of the target analyte(s) contained therein. Suchmechanisms may include electrochemical or colorimetric analysis, asdescribed in connection with the description of the integrated meterspreviously referenced herein.

A device constructed according to further alternative embodiments of thepresent invention is depicted in FIGS. 5-8. The device has aconstruction and functionality which is similar to that of thepreviously described embodiments. Therefore, where a feature of thealternative embodiments finds a corresponding feature with thepreviously described embodiments, they have been given similar referencenumeral (e.g., 12 and 112). Therefore, reference is made to thepreviously described embodiments for a full description of thesecorresponding features.

As illustrated in FIGS. 5-8, the first portion 112 of the device 100 isprovided with a configuration which facilitates handling by a user. Thisis particularly important when the device 100 is intended for use withblood glucose monitors. This is because people with diabetes can lacktactile dexterity. Thus, the first portion 112 of the device 100 can beprovided with any suitable form which facilitates grasp by a user.

According to the illustrated embodiment, the first portion 112 comprisesa flattened relatively wide paddle-like shape. The paddle-like shapeincludes facing surfaces 113 which are contoured in an hourglass typemanner such that the second portion 112 is provided with a cross-sectionthat is relatively thin toward the middle, and wider towards its ends(FIG. 6). The second portion 112 may optionally be provided with afeature that reduces slippage. For example, according to the nonlimitingillustrated embodiment, the second portion 112 is provided with a seriesof raised projections or ribs 115. Alternative features, such as a highfriction surface coating or material disposed on all or a portion ofsurfaces 113 and/or ribs 115 may also be provided.

The second portion 114 of the device 100 defines a reservoir 116, whichhouses a control material 118, which can take any suitable form, such asthat described in connection with the previous embodiments. Thereservoir 116 can be sealed by a corresponding closure or seal 120. Thesecond portion 114 further comprises a flanged 122 body 124, configuredin a manner similar to that of the previously described embodiment.

In the embodiments depicted in FIGS. 5-8, the first portion 112 in thesecond portion 114 are formed as separate components which are assembledtogether and secured in any suitable fashion, such as by adhesive or afastener. However, it should be understood that the invention is not solimited. Namely, the device 100 can have an integral or single-piecemonolithic construction.

It should be evident that the device 100 has a configuration such thatit can be utilized in a manner similar to that of the previousembodiment, as depicted in FIG. 4 herein.

The device of the present invention, and components thereof, can be madeof any suitable material, such as, metal, wood, plastic, etc. In apreferred embodiment, the device can be made of an injection moldedplastic material to simplify production and reduce costs. Similarly, inone optional embodiment, a control solution is absorbed onto a carrierlayer of porous absorbent material that is placed into a reservoir inthe control wand then sealed with a frangible environmental seal, suchas a thin aluminum foil. It is also understood that the control materialcould be placed directly into the cavity in the control wand and sealedwithout a carrier. Instead of a wand-type delivery device of the typepreviously described, the control material delivery device could come inthe form of a:

-   -   blister filled with control material. The foil sealed blister        could still be used to initiate the test as described herein    -   gel-cap filled with control material similar to gel-caps used to        delivery drugs such as OTC pain reducers, or    -   any other method of containing and automatically dispensing an        appropriate dosage of control material.

An example of the above-mentioned alternative control material deliverydevices is illustrated in FIGS. 9-13. This illustrated therein, aplurality of such devices 150 can be coupled or packaged together. Eachindividual control material delivery device 152 is separable by anysuitable mechanism. For instance, the plurality of devices 150 can beprovided with frangible areas 154 for separating the individual devices152 from one another. The frangible areas 154 can be provided by anysuitable mechanism, such as scoring or other weakening of the materialin these areas.

Each individual control material delivery device 152 can be provided inany suitable form. According to the illustrated embodiment, each device152 can comprise a body 156. The body 156 can take any suitable form.According to the illustrated embodiment, the body 156 is in the form ofa strip-like member. The body 156 can be formed from any suitablematerial, such as a plastic, fibrous material, or composite.

Attached to the body 156 is a reservoir 158. The reservoir can beprovided with any suitable construction. For example, the reservoir canbe configured to mate with an opening provided in an analyte monitor ormeter, for example, in the manner previously described in connectionwith the description of FIG. 4. Each reservoir 158 is configured toreceive a control material 160 therein. Each reservoir 158 may also beprovided with a seal 162 to maintain that control material 160 withinthe reservoir 158. The seal 162 can take any suitable form. For example,the seal 162, according to the illustrated embodiment, comprises apierceable member such as a thin metal foil. Thus, the seal 162 mayoptionally be provided with a construction which is pierceable by amember such as a hollow needle, as previously described in connectionwith the embodiment depicted in FIG. 4. Each device 152 may also beprovided with a flange-like member 164 which is also attached to thebody 156 of the device 152. The flange-like member 164 provides rigidityand support to the reservoir 158, and facilitates attachment thereof tothe body 156.

The flange-like member 164 may also include a backing 166 which is notpierceable. Thus, for example, the backing 166 is not pierceable by ahollow needle. This construction of the backing 166 can be provided toprotect the fingers of a user when the reservoir 158 is inserted into ameter or monitor, which includes a piercing element, such as a hollowneedle, which is used to access the control material 160 within thereservoir 158.

Devices constructed according to further alternative embodiments of thepresent invention are depicted in FIGS. 14-30B. These devices have aconstruction and functionality which is similar to that of thepreviously described embodiments. Therefore, where a feature of thealternative embodiments finds a corresponding or feature in common withthe previously described embodiments, they have been given similarreference numerals (e.g., 113 and 213). Therefore, reference is made tothe previously described embodiments for supplemental description ofthese previously described features.

The devices and methods according to the embodiments depicted in FIGS.14-30B have certain features in common. For instance, according to thesealternative embodiments, the device 200 can possess a single piececonstruction, as opposed to a two-piece construction described accordingto other embodiment of the present invention. Each of these embodimentsalso may possess a reservoir constructed to retain a control material inflowable or liquid form, the provision of a porous or absorbent materialas a carrier is not required, however, may be present according tofurther optional embodiments. These embodiments also possess a flexibleneck construction which facilitates alignment and usage of the device,in particular by people with diabetes. The devices of these embodimentscan also be made of any suitable material, such as, metal, wood,plastic, etc. According to one option, the device can be made of aninjection molded plastic material to simplify production and reducecosts.

As illustrated, for example, in FIGS. 14-17, the first portion 212 ofthe device 200 is provided with a configuration which facilitateshandling by a user. This is particularly important when the device 200is intended for use with blood glucose monitors. This is because peoplewith diabetes can lack tactile dexterity. Thus, the first portion 212 ofthe device 200 can be provided with any suitable form which facilitatesgrasp by a user.

According to the illustrated embodiment, the first portion 212 comprisesa flattened relatively wide paddle-like shape. The paddle-like shapeincludes facing surfaces 213 which are contoured in an hourglass typemanner such that the second portion 212 is provided with a cross-sectionthat is relatively thin toward the middle, and wider towards its ends(FIGS. 15-16). The first portion 212 may optionally be provided with afeature that reduces slippage. For example, according to the nonlimitingillustrated embodiment, the first portion 212 is provided with a seriesof raised projections or ribs 215. Alternative features, such as a highfriction surface coating or material disposed on all or a portion ofsurfaces 213 and/or ribs 215 may also be provided.

The device 200 may further include a second portion 214 with a flexibleneck construction 230. The flexible neck 230 facilitates usage of thedevice by permitting relative movement between the first portion 212 andsecond portion 214 of the device. The flexible neck 230 can facilitateuse of the device 200 in connection with mating the body 224 with anopening in a meter. The relative movement between the first portion 212and the second portion 214 facilitates keeping the flanged 222 body 224pressed flat against the opening, thus improving the ability to form aseal therewith. The flexible neck 230 may possess any suitableconstruction permits this desired relative movement. Thus, the flexibleneck may simply comprise a relatively thin neck of flexible material, orother alternative configurations. According to the illustrated examples,the flexible neck 230 comprises a series of sections 231 interconnectedby one or more thin flexible necks 232.

The second portion 214 of the device 200 can define a reservoir 216,which houses a control material 218, as described in connection with theprevious embodiments. Optionally, the control material 218 can containone or more target analytes having a known and/or predeterminedconcentration and can be in liquid or flowable form as illustrated in,for example, FIGS. 16-17. The reservoir 216 can be sealed by acorresponding closure or seal 220. The second portion 214 furthercomprises a flanged 222 body 224, configured in a manner similar to thatof the previously described embodiment.

According to certain alternative embodiments, the device 200 can includeone or more features which allow the user to urge the control materialout of the device so as to deliver it to its intended location. A numberof such features are contemplated, including the use of positive and/ornegative pressures. According to one nonlimiting, specific example, asillustrated in FIG. 18, the first portion 212 of the device 200 cancomprise a hollow interior region 260. Further, the second portion 214of the device may also comprise a hollow region 262, which is preferablyin communication with the first hollow region 260. Thus, the user isable to grasp the handle 213 and squeeze in the direction of thehorizontal arrows appearing in FIG. 18. This compression of hollowregion 260 forces any air, or other fluid, contained therein in thedirection of the vertical arrow. The forced fluid then travels throughthe second hollow region 262 and into the reservoir 216, where it thenacts to force the control material 218 out the opening of the reservoir216. It should be evident that any of the previously or subsequentlydescribed embodiments can be modified in a suitable manner, similar tothat described above, to provide the same optional functionality.

As mentioned above, in the embodiments depicted in FIGS. 14-24 the firstportion 212 in the second portion 214 are integrally formed or comprisea single-piece monolithic construction. However, the invention is not solimited and can be formed in multiple parts that are either permanentlyor releasably connected together.

It should be evident that the device 200 has a configuration such thatit can be utilized in a manner similar to that described in connectionwith the previous embodiments.

The device 200 illustrated in FIGS. 19-20 has the same features as thedevice 200 described above. As illustrated in FIGS. 19-20, the device200 according to this alternative embodiment possesses a gasket or seal240 disposed about the body 224 and abutting the flange 222. The gasket240 can be formed from any suitable material, natural or synthetic. Forexample, the gasket 240 can be formed from foam, rubber, cork material,or a composite. The gasket 240 can be a separate component that isfitted over the body. When formed as a separate component, the gasketcan be held in place by friction or by a suitable adhesive.Alternatively, the gasket 240 can be co-molded with the device 200 so asto be unified therewith. The gasket 240 enhances a seal formed betweenthe flanged 222 body 224 when the device 200 is used in conjunction andmated with an opening of a meter, as will be described in greater detailherein.

The device 200 illustrated in FIGS. 21-22 has the same features as thedevice 200 described above. As illustrated in FIGS. 21-22, the device200 according to this alternative embodiment possesses an alternativeclosure 250 for the reservoir 216. The alternative closure 250 can haveany suitable construction. According to the optional illustratedembodiment the closure 250 comprises a handle or hinge 252 connected tothe flanged 222 body 224. The hinge 252 can be connected in any suitablefashion. According to the illustrated embodiment, the hinge 252 isintegrally formed with the flanged 222 body 224, such as by molding.Alternatively, the hinge may be separately formed and secured in placeby adhesive, heat welding, ultrasonic welding or other suitabletechnique. The hinge may also include a ring or collar that fits aroundthe body 224 to secure the hinge 252 in place. The closure 250 mayfurther include a cap portion 254 that mates with reservoir 216 openingforming a seal therewith to contain the control material 218 containedtherein (FIG. 16). According to one optional embodiment, the cap portion254 can be pressed down and lifted up by a user to form a re-sealableclosure. Alternatively, the cap portion 254 can be secured in place tothe flanged 222 body 224 by adhesive, heat welding, ultrasonic welding,or other suitable technique. The cap portion may comprise a frangibleportion 256. The frangible portion 256 can be constructed so that it ispierceable by a lancet, needle, or similar modality.

The device 200′ illustrated in FIGS. 23-24 can share any combination orall of the same features as the device 200 of the previously describedembodiments. The main distinction is that device 200′ has two secondportions 214A, 214B, each with a flexible neck construction 230A, 230Boptionally provided with a construction previously described herein.Each second portion 214A, 214B of the device 200′ defines a reservoir216A, 216B which houses a control material 218A, 218B. The controlmaterial 218A, 218B can be essentially the same, thus providing theability to perform at least two similar control tests with the samedevice 220′. As previously described, the control material may containone or more target analyte(s). Alternatively, the control material 218Acan differ from the control material 218B in one or more respects. Forexample, the first control material may contain a relatively lowerconcentration of a target analyte, while the second control material maycontain a relatively higher concentration of the target analyte, thusproviding a single device 200′ with the ability to conduct a controltest for both low and high analyte concentration ranges to ensure evengreater accuracy of a meter or other measuring device. According to afurther option, the control materials 218A, 218B can be used to performa control test for at least two different target analytes. Thus, thefirst control material 218A can have a know concentration of a firstanalyte, while the second control material 218B can have a knownconcentration of a second analyte. The reservoirs 223A, 223B can besealed by a corresponding closure or seal 220A, 220B, as illustrated.Alternatively, the closure can be constructed as illustrated anddescribed above in connection with FIGS. 21-22. The second portions214A, 214B can have either the same type of closure or seal, ordifferent types of closures/seals.

According to further optional embodiments of the present invention, anyof the previously or subsequently described embodiments can be modifiedso as to include an alternative reservoir construction, an example ofwhich being illustrated in the embodiments depicted in FIGS. 25-26. Asillustrated therein, the second portion 214 of the device includes amodified reservoir 216′. The modified reservoir 216′ can be generallycharacterized as being in the form of a separable multi-piececonstruction. Such a construction can provide certain advantages. Forexample, the separable reservoir component containing the controlmaterial can be in the form of a cartridge which can be inserted into areusable handle portion constituting the remainder of the device. Thus,once the control test has been conducted, the separable reservoircomponent containing control material can be removed and discardedappropriately. Such a construction may provide advantages in terms ofcost and convenience, as well as significantly reducing waste due to thereusability of the handle portion. Further, the separable reservoircomponent containing the control material can be formed of a materialwhich is different in nature than that of the handle portion into whichit is inserted. For instance, the separable reservoir component can beformed from a relatively low moisture vapor transmission rate (LMVTR)material. Thus, the control material is kept in a more stable mannerthat would be possible using a higher moisture vapor transmission ratematerial. To the extent that the LMVTR material is more costly than arelatively higher moisture vapor transmission rate material, costsavings can be obtained through the above-mentioned modified reservoirconstruction.

The above noted concepts can be executed in any suitable manner.According to the nonlimiting illustrated embodiment, the modifiedreservoir portion 216′ comprises a lower member 270 defining a recess272 therein. Received within a recess 272 is a separable reservoircomponent 274 containing the control material 218. The separablecomponent may be closed by a frangible seal 220, as previouslydescribed, As noted above, this separable component 274 can be formed ofany suitable material, such as a LMVTR plastic material. The separablecomponent 274 can be retained within the recess 272 in any suitablefashion. Contemplated alternatives include adhesives, fasteners, andfrictional retention. According to the illustrated embodiments, theseparable component 274 is retained within the recess 272 by pluralityof interacting frictional detents 276, 278.

Further aspects of the invention involves analyte testing/monitoringdevices and methods including the devices (e.g., 100, 200, 200′) of thetype described above in conjunction with an integrated analyte monitoror meter. The integrated monitor or meter optionally being capable ofone or more of the following:

-   -   extracting the control material    -   transporting the control material to an analysis site within the        integrated monitor (e.g., as described in several of the        integrated meter documents incorporated herein by reference)    -   analyzing the control material to determine the concentration of        the analyte contained in the fluid    -   analyzing the control to determine whether the sample is a body        fluid or a control material    -   comparing the result of the control test against a control        calibration value, which may be read off a barcode, RFID, or        similar device and/or stored in a memory of the monitor or        meter, and    -   displaying the result of the control test as a        simple-to-interpret pass or fail result through simple        audible/visual signals.

To complete the described steps automatically the analyte monitor shouldalso have the capability of gathering calibration informationautomatically, such as from an analyte concentration measuring andanalysis mechanism contained with the device. If analysis site(s) is/arecontained within a single strip or multi-test cartridge CR, asillustrated in FIG. 27, the calibration information for the analyteconcentration measuring and analysis mechanism(s) could be delivered tothe meter or monitor M via a bar code BR, RFID chip CH or othermechanism.

One advantage of the invention is automated detection and marking of acontrol test to distinguish that test from, for example, a testinvolving a sample of body fluid. This can be accomplished by severalmethods; one method of identifying a control test is described asfollows. The control material can be designed such that it reacts withthe analysis site in a manner distinguishable from the reaction with abodily fluid. For example, the viscosity of the control material can beso different, either lower or higher than the tested body fluid, thatthe rate of reaction or sample delivery can be used to distinguishcontrol material from body fluid. Specifically, glucose monitorstypically have stated hematocrit ranges that are acceptable for use withthe device. As hematocrit increases the viscosity of blood alsoincreases. The analysis site and method could be designed in such amanner that the rate of reaction is inversely related to hematocrit(higher hematocrit=slower reaction). This has been described, forexample, in US 2006/0281187, the entire contents of which isincorporated herein by reference. To accomplish this, the controlmaterial used within the analysis site could be contained in a porousmaterial. The size of the pores in the material can be used to controlthe rate of reaction. The control fluid can be designed such that itsviscosity is lower than the equivalent viscosity of the lowest allowablehematocrit level. Therefore as the analysis is completed within theintegrated monitor the rate of reaction can be used to identify controlmaterial tests.

Another method of identifying a control sample versus a body fluidsample involves adding identifying markers to the control material. Forexample, control material could be identified by optical detection byadding color within the detection wavelength such that a color change ofan order of magnitude higher than physiologically possible given thekinetics of the assay occurs nearly instantaneously. The degree of coloradded via a dye or other colored means is enough to detect via thismethod, but not so much as to reduce the dynamic detection range of thesystem so that the proper level of analyte detection in the controlmaterial can correctly indicate system analyte recovery status as “Pass”or “Fail” through clear audible and/or visual signals. Another similaroption that may be implemented is to provide the control material with achemical marker that initially reacts with the analysis site to producean initial spike in color indicating to the meter the presence ofcontrol solution. The initial color spike can be designed to quicklydisappear. Subsequently, the analysis site reacts with the analyte(s) ina manner that can be read and interpreted to determine the concentrationthereof.

Other similar methods of observing the time rate of change of theanalysis site (reagent) are also comprehended, i.e., very slow reaction,or reactions proceeding along known value vs. time plots, etc.

According to further alternative embodiments, the automateddetermination of a control solution test can be accomplished usingalgorithms executed by the electronic components within a monitor ormeter.

A method performed according to the principles of one embodiment of thepresent invention includes one or more of the steps in FIGS. 27 and28A-28D:\

Step 1: Provide calibration information to the monitor or device (e.g.,FIG. 27 as described above).

Step 2: Use control material applicator (100, 200, 200′) to deliver adose of control material to monitor or device (M) (FIG. 28A). Note: Theintegrated monitor can optionally detect the presence of a “finger,” inthis case the control wand (100, 200. 200′), and automatically lancesthe closure (20, 120, 220, 256) and transports the control material (18,118, 218) (e.g., FIG. 4).

Step 3: Integrated monitor analyzes the control material and determinesthat sample is a control test as indicated by any suitable symbol, suchas the “check-mark” symbol on LCD (FIG. 28B). Alternatively, the monitormay provide an audible signal in place of, or in addition to, thesymbol.

Step 4a: Control material is analyzed and its analyte concentrationvalue is displayed (e.g., 100 mg/dL) and compared against storedcalibration values. In this example, the value is within the expectedrange and device displays any suitable symbol, such as the “check”indicating “pass” (FIG. 28C). Alternatively, the monitor may provide anaudible signal in place of, or in addition to, the symbol.

Step 4b: Control material is analyzed, the measured analyteconcentration displayed and found to be outside of the expected range.In this case, the monitor indicates a failed test by displaying anysuitable symbol, such as crossed-out check mark. Alternatively, themonitor may provide an audible signal in place of, or in addition to,the symbol. Note the “i” symbol indicates that user should look atmanual to see how to address the failed test (FIG. 28D).

An alternative method performed according to a further optionalembodiment is illustrated in FIGS. 27 and 29A-29D, and is described asfollows.

Step 1: Provide calibration information to the monitor or device (e.g.,FIG. 27 as described above).

Step 2: Use control material applicator (100, 200, 200′) to deliver adose of control material (18, 118, 218) to monitor or device (M) (FIG.29A). Note: The integrated monitor can optionally detect the presence ofa “finger,” in this case the control wand (100, 200, 200′), andautomatically lances the closure (20, 120, 220, 256) and transports thecontrol material (e.g., FIG. 4). The monitor M can optionally signal theuser when the applicator can be removed from the opening.

Step 3: Integrated monitor analyzes the control material and determinesthat sample is a control test as indicated by any suitable symbol, suchas the “check-mark” symbol on LCD (e.g., FIG. 29B). Alternatively, themonitor may provide an audible signal in place of, or in addition to,the symbol.

Step 4a: Control material is analyzed and its analyte concentrationvalue is compared against stored calibration values. In this example,the value is within the expected range and device displays any suitablesymbol, such as the “check” and a “P” indicating “pass” (FIG. 29C).Alternatively, the monitor may provide an audible signal in place of, orin addition to, the symbol. Additional and/or alternative visual andaudible signals are contemplated. For example, the meter M can play arecorded spoken “pass” message. Note that unlike the previousembodiment, the concentration of analyte measured by the device is notdisplayed. It has been found that some users can become confused by thedisplay of a concentration value and mistakenly assume it is a readingof the concentration of analyte in a sample of the user's body fluid,and engage in treatment (e.g., insulin dosage) based on thismisunderstanding of the concentration value displayed by the meter M.This embodiment avoids such opportunity for misinterpretation.

Step 4b: Control material is analyzed, the measured analyteconcentration value is compared by the meter M against stored control orcalibration values and found to be outside of the expected range. Inthis case the monitor displays a fail test. Any suitable symbol, such asthe symbol indicated by the crossed check mark and “F,” indicative of afailed control test. Additional and/or alternative visual and audiblesignals are contemplated. For example, the meter M can play a recordedspoken “fail” message. Note the “i” symbol indicates that user shouldlook at manual to see how to address the failed test (FIG. 29D).

It should be understood that the present invention is not limited to useof the devices (100, 200, 200′) described herein with a particular typeof meter or device. The present invention contemplates devices andmethods that do not rely upon an integrated type meter or monitor. Forexample, many commercially available blood glucose monitoring systemsinclude a lancing device, test strips and meter, one or more of whichare separate components of the system. An arrangement and a controltesting method performed according to an alternative embodiment of thepresent invention is illustrated in FIGS. 30A-30B. As illustratedtherein, a device of the type described herein (100, 200, 200′) containsa control material C. The control material C can have any suitable formor composition as previously described herein (18, 118, 218). Thecontrol material C is accessed by any suitable measure, such as by usinga separate lancing device L that is commonly part of non-integratedblood glucose monitoring systems to pierce the closure or seal of thereservoir containing the control material C (FIG. 30A). A test strip Sused for analyzing the concentration of a target analyte in a sample ofbody fluid by know techniques is inserted into a non-integrated meterM2. Using the device (100, 200, 200′) the control material C is appliedto a test strip S in a manner similar to how the user would introduce asample of body fluid, such as blood obtained from a finger prick. Thecontrol material is then analyzed by the strip S and meter M2 in anysuitable manner in order to verify whether or not the measuredconcentration of analyte in the control material C is within a tolerableexpected range, and the results presented to the user, This can be donein any suitable manner, such as described herein in connection withprevious embodiments.

According to one optional modification of the above described embodimentof FIGS. 30A-30B, instead of using the device (100, 200, 200′) to applythe control material C directly to the test strip S, the control may beapplied directly to the surface of a finger. The test strips is thenbrought into communication with the control material C on the finger,and is transported therein for analysis. This procedure more closelymimics a finger prick test using such non-integrated meters, and thusmay be easier for the user to practice due to the familiarity of steps.

Numbers expressing quantities of ingredients, constituents, reactionconditions, and so forth used in this specification are to be understoodas being modified in all instances by the term “about”. Notwithstandingthat the numerical ranges and parameters setting forth, the broad scopeof the subject matter presented herein are approximations, the numericalvalues set forth are indicated as precisely as possible. Any numericalvalue, however, may inherently contain certain errors necessarilyresulting from the standard deviation found in their respectivemeasurement techniques. None of the elements recited in the appendedclaims should be interpreted as invoking 35 U.S.C. §112, ¶6, unless theterm “means” is explicitly used.

Although the present invention has been described in connection withpreferred embodiments thereof, it will be appreciated by those skilledin the art that additions, deletions, modifications, and substitutionsnot specifically described may be made without departing from the spiritand scope of the invention as defined in the appended claims.

1. A device comprising: a first portion configured to be grasped by thehand of the user; and a second portion defining a reservoir containing afirst control material, wherein the control material comprises a targetanalyte of a known or predetermined concentration.
 2. The device ofclaim 1, further comprising a frangible seal which contains the controlmaterial within the reservoir, and shields the control material fromexposure to the environment.
 3. The device of claim 1, wherein thecontrol material comprises a control liquid or solution.
 4. The deviceof claim 3, wherein the control material comprises an absorbent materialupon which the control liquid or solution is absorbed.
 5. The device ofclaim 1, wherein the second portion further comprises a body shaped andconfigured to mate with an opening disposed in an analyte monitor. 6.The device of claim 5, wherein the second portion further comprises aflange which is configured to limit the depth of insertion of the secondportion into the analyte monitor.
 7. The device of claim 6, furthercomprising a gasket arranged to abut the flange.
 8. The device of claim1, wherein the first portion is in the form of a flattened paddle-likeshape.
 9. The device of claim 8, wherein the first portion has across-section which is relatively thin at its middle, and relativelywider at its ends.
 10. The device of claim 9, further comprising aslippage reducing feature.
 11. The device of claim 10, wherein theslippage reducing feature comprises one or more ribs disposed on thefirst portion.
 12. The device of claim 1, wherein the first portion andthe second portion are formed as separate components which are joinedtogether.
 13. The device of claim 1, wherein the first and secondportions are integrally formed.
 14. The device of claim 13, wherein thefirst and second portions are part of a one-piece monolithic structure.15. The device of claim 1, wherein the second portion comprises aflexible neck, the flexible neck permitting relative movement betweenthe first portion and the second portion of the device.
 16. The deviceof claim 1, wherein the first portion comprises a first hollow interior,and the second portion comprises a second hollow interior, wherein thefirst hollow interior and the second hollow interior are in fluidcommunication with each other, and wherein the first hollow interior andsecond hollow interior are in fluid communication with the reservoir.17. The device of claim 16, wherein the first hollow interior iscollapsible, thereby forcing the control material out of the reservoir.18. The device of claim 1, wherein the reservoir comprises a separablereservoir component.
 19. The device of claim 18, wherein the secondportion comprises a recess adapted to receive the separable reservoircomponent.
 20. The device of claim 19, wherein the separable reservoircomponent is frictionally retained within the recess in a releasablemanner.
 21. The device of claim 2, wherein the frangible seal comprisesa pierceable foil.
 22. The device of claim 2, wherein the frangible sealcomprises a hinge and a cap portion configured to mate with and seal thereservoir.
 23. The device of claim 1, further comprising a third portiondefining a reservoir containing a second control material.
 24. Thedevice of claim 23, wherein the first and second control materials aresubstantially the same.
 25. The device of claim 23, wherein the firstand second control materials are different.
 26. The device of claim 1,wherein the control material further comprises at least one markerindicative of the presence of the control material.
 27. The device ofclaim 26, wherein the marker is composed to produce a color changepossessing a degree of magnitude such that it is indicative of thepresence of the control material.
 28. The device of claim 27, whereinthe marker comprises a dye.
 29. The device of claim 26, wherein themarker is composed to produce a temporary color change indicative of thepresence of the control material.
 30. In combination, an integratedmeter comprising a housing with an opening formed therein, and thedevice of any of claim 1, the second portion comprising a body and aflange shaped and configured to be received by the opening in theintegrated meter.
 31. The combination of claim 30, wherein devicefurther comprises a frangible seal covering the reservoir, and theintegrated meter further comprising a hollow piercing elementconstructed and arranged to pierce the seal and convey the controlmaterial toward a location within the meter for analysis.
 32. A methodof conveying a control material to an analyte monitor, the methodcomprising: (i) providing a dispenser comprising a first portionconfigured to be grasped by the hand of the user, and a second portiondefining a reservoir having a frangible seal thereon, the reservoircontaining a control material, wherein the control material comprises atarget analyte in a known and/or predetermined concentration; (ii)breaking the frangible seal; and (iii) conveying the control material toa location for analysis by the analyte monitor.
 33. The method of claim32, wherein the second portion comprises a body shaped and configured tomate with the analyte monitor.
 34. The method of claim 32, the methodfurther comprises piercing the frangible seal, and conveying the controlmaterial to the location within the analyte monitor for analysis. 35.The method of claim 32, wherein the control material comprises a controlliquid or solution.
 36. The method of claim 32, wherein the controlmaterial comprises an absorbent material upon which the control liquidor solution is absorbed.
 37. The method of claim 32, wherein the secondportion further comprises a flange which is configured to limit thedepth of insertion of the second portion into an opening disposed in theanalyte monitor.
 38. The method of claim 32, the method furthercomprising sensing the presence of the second portion of the dispenser.39. The method of claim 32, the method further comprising distinguishingbetween the control material and a body fluid without intervention fromthe user.
 40. A method of verifying the accuracy of the operation of ananalyte monitoring device using a control material having a known and/orpredetermined concentration of at least one analyte, the methodcomprising: providing a single or multi-test cartridge havinginformation associated therewith defining an acceptable range ofmeasured analyte concentration values for the control material;associating the single or multi-test cartridge with the device; readingthe information off the single or multi-test cartridge; introducing acontrol material to the single or multi-test cartridge; the deviceautomatically determining the presence of a control material; analyzingthe control material to measure the concentration of analyte containedtherein; and comparing the measured concentration with the informationto determine if the measured concentration corresponds to the acceptablerange of concentration values obtained from the information.
 41. Themethod of claim 40, wherein the at least one analyte comprises glucose.42. The method of claim 40, wherein the cartridge comprises a multi-testcartridge.
 43. The method of claim 40, wherein the information iscontained in a bar code or RFID chip associated with a single ormulti-test cartridge.
 44. The method of claim 40, further comprisingstoring the information read off the single or multi-test cartridge in amemory of the device.
 45. The method of claim 40, wherein the controlmaterial is introduced to the single or multi-test cartridge using adevice as defined in any of claims 1-19.
 46. The method of claim 40,wherein the control material was analyzed using a colorimetrictechnique.
 47. The method of claim 40, further comprising providing apass or fail signal to indicate whether or not the measuredconcentration falls within the acceptable range of concentration values.